Clinical Trials - Planning, Implementation and Monitoring

Swiss TPH has a strong expertise in planning, implementing and monitoring clinical trials especially in low-resource countries. Besides conducting own clinical research projects, Swiss TPH features a contract research organisation that plans, assists and conducts clinical research trials for academic and non-academic clients. The core team is supported by a large network of regional monitors and experts in various disease areas coming from the Swiss TPH.

Offered Services for Clinical Trials

Developing new drugs and vaccines against neglected tropical diseases is challenging. Clinical trials have to take place in rural areas, which often lack basic health infrastructure. We have long-term experience and provide services in clinical trials following strict ethical standards and professional regulations. Services includes support for planning and conducting clinical studies phase I-IV, clinical monitoring to Good Clinical Practice standards and support of investigator-inititated studies.

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Selected projects at this location:

Swiss TPH has acquired a significant wealth of experience in conducting often complex clinical trials exposed to a multitude of cultural, scientific and operational challenges. Our focus is on the development of drugs and vaccines against tropical and poverty-related diseases.

Focus on Tropical Diseases

Our recent and current spectrum of indications includes malaria, tuberculosis, human African trypanosomiasis (sleeping sickness), schistosomiasis and ebola. All these diseases have a huge impact on society and economy and some of them are considered neglected tropical diseases.

Successful Projects Due to Our International Network

Swiss TPH can rely on extensive and long-standing international network of collaborating professionals, organisations and institutions. It enables us to operate flexible and resource effective and assures that local particularities are respected in our projects. We are adept in conducting projects successfully in countries like Côte d’Ivoire, the Democratic Republic of the Congo, Kenya, South Africa, Tanzania or Uzbekistan.

Fexinidazole against African Human Trypanosomiasis

Human Africa Trypanosomiasis is a life-threatening neglected disease. To date nifurtimox-eflornithine combined therapy (NECT) is the Standard Treatment for late-stage HAT. Nevertheless, NECT is still far from ideal given the environment in which HAT patients live. There is an urgent need to develop less toxic and easier-to-use products. One promising agent is Fexinidazole.

Link to Project

Pediatric Praziquantel Formulation for Treating Schistosomiasis

Schistosomes, parasitic blood flukes, cause the chronic disaese schistosomiasis. Today, the gold standard of treatment is praziquantel which is only suitable for adults and school-aged children. Thus, a palliative, effective and safe praziquantel formulation to treat young children is absolutely required. To reach this aim, the Pediatric Praziquantel Consortium was founded in 2012.

Link to Project

Treatment of Multidrug-Resistant Tuberculosis

Tuberculosis is one of the most deadly infectious diseases in the world. Treatment is complex especially in case of multidrug-resistant tuberculosis. Particularly patients in low-resource countries often lack access or do not complete treatment regimen. TB PRACTECAL is a pioneering new clinical trial aiming to find a radically improved course of treatment for drug-resistant tuberculosis.

Link to Project

The conduct of clinical trials in low resource countries and particularly in rural areas entails numerous challenges which have to be addressed and solved to meet the international ethical and regulatory standards, as well to respect the cultural background of the respective country and population.

Capacity is Often Insufficient

The technical installations of the facilities and the training level of the personnel may not always meet the needs for the appropriate conduct of clinical trials. Therefore, such projects typically involve considerable logistic and training efforts.

Profound Knowledge is Required

Last but not least, the conduct of clinical trials on tropical diseases requires a profound medical, epidemiological and biological understanding of the illness and the confounding factors to allow a competent planning, conduct and evaluation of a trial.

 

 

In developing countries and particularly rural areas adequate capacities including human resources and infrastructure may not be guaranteed. One goal of Swiss TPH is building and strengthening local capacities to allow qualified work. We offer support for center assessment and selection, for local regulatory affairs and logistics as well as in training staff in good clinical practice.

Office in Kinshasa

Due to our long-term commitment in countries like the Democratic Republic of the Congo (DRC), for example, new sustainable research platforms have emerged and can serve as future clinical trial sites. In 2005, we established an external office in Kinshasa and in 2015 the Swiss TPH has been registered as an NGO in the DRC. 

The current project project portfolio in the DRC comprises several research and capacity strengthening projects on malaria and several clinical trials on human African trypanosomiasis (sleeping sickness). The Swiss TPH office is also the basis of the Alliance for Clinical Research and Clinical Epidemiology in the DRC (ARCEAU-RDC) and our direct link to the various partner organisations and clients in the DRC.